GUEST CONTRIBUTORS

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PHARMA OUTSOURCING WHITE PAPERS

Utilizing External Collaboration To Accelerate Vaccine Development Utilizing External Collaboration To Accelerate Vaccine Development

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

Buffer Management Solutions For Large-Scale Bioprocessing

How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Partnering With Your Teams To Enhance And Increase Supply Chain Efficiency

Emerging biopharmaceutical company teams up with clinical services company to stay on track with timelines and ensure funding milestones were met when faced with unexpected lack of bandwidth and limited global organizational experience.

Gaps In Traditional Reconstitution Process Filled By Water-For-Injection Syringe
Since the 1930s, pharmaceutical manufacturers have leveraged a method called “lyophilization” to reconstitute freeze-dried drugs from which water has been removed into liquid form. The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly. By Mike Schaefers, Vice President of Marketing for Europe, West Pharmaceutical Services, and Thomas Otto, Managing Director, Vetter
Single-Use Stirred Tank Fermentor System Performance Comparison

The process design proven for one fermentor system is not always directly transferrable to other system formats without adaptation. Here, we compare the performance of the XDR‑500 MO fermentor with the XDR‑50 MO system.

Case Study: Large Scale Stability
As a drug product enters into the later clinical phases, there is a requirement to support large registration stability studies. A large European client sought Aptuit’s substantial resources to conduct large scale stability testing. By Aptuit, Inc.
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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Annual Cardiologists Meeting 2018 November 26 - 27, 2018
Madrid)
Blockchain Technology for the Life Sciences: A Comprehensive Primer November 27 - 27, 2018
1pm-2:30pm EST, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Compliant Patient Support Programs Summit November 28 - 29, 2018
Philadelphia, PA)
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